MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXPRESS LD ILIAC / BILIARY; STENT, ILIAC

Model Number	20226
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the device was received for analysis.No kinks or damage were visible along the entire length of the device.A visual and microscopic examination was performed on the returned device.A visual examination of the device found that the balloon had been inflated and the stent of the device had been deployed.The deployed stent was not returned for analysis.No tears or holes were present in the balloon.As part of the functional testing the device was attached to an encore inflation unit and during an attempt to inflate the balloon to its rated burst pressure, a pressure drop was identified prior to reaching the rated burst pressure.Liquid was noted to be exiting from the guidewire port of the hub.The investigator clamped the shaft of the device in increments, beginning at the balloon and working towards the hub, in an attempt to identify the location of the breach between the inflation lumen and the guidewire lumen.No lumen breach was identified in the shaft section.The shaft was clamped at the distal edge of the hub and liquid continued to exit the guidewire port.
Event or Problem Description
Reportable based on device analysis completed on 28-feb-2019.An 8.0x20x75cm express ld iliac/biliary stent was received with no reported issues.However, returned device analysis revealed a displaced stent.

• Brand Name: EXPRESS LD ILIAC / BILIARY
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8382390
• Report Number: 2134265-2019-01878
• Device Sequence Number: 11264154
• Product Code: NIO
• UDI-Device Identifier: 08714729392255
• UDI-Public: 08714729392255
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K133110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/25/2021
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0021908619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2019
• Initial Report FDA Received Date: 03/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1